| CTRI Number |
CTRI/2015/03/005622 [Registered on: 11/03/2015] Trial Registered Retrospectively |
| Last Modified On: |
06/03/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A RANDOMIZED CONTROL TRIAL TO STUDY THE VARIATION OF PLASMA CONCENTRATIONS OF ONCE DAILY INTRAVENOUS VERSUS INTRAMUSCULAR GENTAMICIN IN INFANTS |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL TRIAL TO STUDY THE PHARMACOKINETICS OF ONCE DAILY INTRAVENOUS VERSUS INTRAMUSCULAR GENTAMICIN IN INFANTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Kumar Kulhare |
| Designation |
Senior Resident |
| Affiliation |
Lady Hardinge Medical College, New Delhi |
| Address |
Department of Pharmacology, near Director office, Lady
Hardinge Medical College, Shaheed Bhagat Singh Marg,New Delhi
Central
DELHI
110001
India |
| Phone |
09711709148 |
| Fax |
|
| Email |
sumit.kulhare@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harmeet Singh Rehan |
| Designation |
Head of Department |
| Affiliation |
Lady Hardinge Medical College, New Delhi |
| Address |
Department of Pharmacology, near Director office, Lady
Hardinge Medical College, Shaheed Bhagat Singh Marg,New Delhi
Central
DELHI
110001
India |
| Phone |
09711709148 |
| Fax |
|
| Email |
harmeetrehan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Kumar Kulhare |
| Designation |
Senior Resident |
| Affiliation |
Lady Hardinge Medical College, New Delhi |
| Address |
Department of Pharmacology, near Director office, Lady
Hardinge Medical College, Shaheed Bhagat Singh Marg,New Delhi
Central
DELHI
110001
India |
| Phone |
09711709148 |
| Fax |
|
| Email |
sumit.kulhare@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Department of Pharmacology, Ground Floor, near Director Office, Lady Hardinge Medical College, Shahid Bhagat Singh Marg, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumit Kumar Kulhare |
Lady Hardinge Medical College |
Department of Pharmacology, near Directors office, Lady
Hardinge Medical College, Shaheed Bhagat Singh Marg
Central
DELHI |
9711709148
sumit.kulhare@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infants age less than 6 months suffering from bacterial infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intramuscular Gentamicin |
Infants found suitable as per inclusion criteria were administered intramuscular gentamicin (5mg/kg). Blood samples (2ml) were taken from each patient to determine peak and trough levels of gentamicin - after 60 minutes for peak levels at the end of intramuscular gentamicin injection and after 18 hrs for trough levels. |
| Comparator Agent |
Intravenous Gentamicin |
Infants found suitable as per inclusion criteria were administered intravenous gentamicin (5mg/kg). Blood samples (2ml) were taken from each patient to determine peak and trough levels of gentamicin - after 30 minutes for peak levels at the end of intravenous gentamicin injection and after 18 hrs for trough levels. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
All infants of age less than or equal to 6 months admitted to a Paediatric unit of Kalawati Saran Children Hospital, New Delhi with suspected or confirmed infections considered suitable for gentamicin therapy such as,
i. Suspected Gram-negative sepsis,
ii. Infections like acute enteritis, pneumonia, meningitis and septic arthritis, and
iii. Urinary tract infection (UTI)
|
|
| ExclusionCriteria |
| Details |
i. Age greator than 6 months
ii. Abnormal renal functions (serum urea and creatinine).
iii. Earlier diagnosed cases of impaired internal ear function or deafness.
iv. Severely ill patients or those with life-threatening infections. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peak and Trough serum gentamicin concentrations (SGCs) post single dose of intravenous gentamicin and intramuscular gentamicin injections. |
After 30 minutes and 60 minutes of IV and IM administration of gentamicin respectively, to determine serum peak levels of gentamicin. To estimate trough serum gentamicin levels after 18 hours of administration of gentamicin by either route. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary Outcomes |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/04/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Gentamicin is frequently used for the treatment of serious bacterial infections in neonates and infants. Gentamicin can be administered either intravenously or intramuscularly. Intravenous administration of gentamicin has 100% bioavailability and achieves the peak serum concentration within 30 minutes of its administration but is associated with iatrogenic complications like infection,phlebitis,extravasation,air embolism,hemorrhageand hematoma. In addition, intravenous therapy requires skilled health workers viz nurse to administer it. On the other hand, intramuscular administration of gentamicin has less chance of such iatrogenic complications and is also convenient to administer.However, there is limited data on the pharmacokinetics of intramuscular gentamicin in infants. It was assumed that single daily dose of intramuscular gentamicin may have comparable serum peak and trough levels with that following intravenous administration for treating serious bacterial infections in infants. To further establish this, present study was conducted to compare the pharmacokinetics of once daily intramuscular gentamicin versus once daily intravenous gentamicin in young infants suffering from serious bacterial infections.
The findings of this study suggested that IV and IM gentamicin have comparable pharmacokinetics (peak and trough concentrations). Therefore, health centres in developing countries where there are limited available resources including trained health care professionals to administer intravenous injection, intramuscular route to administer gentamicin in young infants should be preferred. |